Clinical trial · Interventional
Gastrointestinal Microbiome Study of Appendiceal Cancer
A Cohort Study of the Gastrointestinal Microbiome in Appendiceal Cancer With Peritoneal Spread
NCT02599116CI-TRIAL-00065029unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study analyzes the gastrointestinal microbiome of appendiceal cancer patients with peritoneal spread scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC). Participants will provide fecal samples pre- and post-operatively.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Appendiceal Neoplasm | Appendix Neoplasm | ALIAS | 0.90 |
| Cancer, Appendiceal | Malignant Appendix Neoplasm | ALIAS | 0.90 |
| Pseudomyxoma Peritonei | Pseudomyxoma Peritonei | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bio-specimen collection | Other | — | UNRESOLVED |
| Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Microbiome cohort
- description
- 1. Pre-operative (baseline) bio-specimen collection (fecal sample) and completion of two food and lifestyle questionnaires. 2. Six to twelve weeks following cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC), post-operative bio-specimen collection (fecal sample) and completion of two food and lifestyle questionnaires 3. Six to twelve months following cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC), post-operative bio-specimen collection (fecal sample) and completion of two food and lifestyle questionnaires
- interventionNames
- Other: Bio-specimen collection
- Other: Questionnaire
Primary outcomes (1)
- measure
- Determine whether the intestinal microbiome of patients with appendiceal tumors with peritoneal carcinomatosis differs from that of a healthy, age-matched cohort
- timeFrame
- 36 months
- description
- Appendiceal cohort to healthy age-matched cohort
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of appendiceal cancer with peritoneal spread * Candidate for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) * ≥18 and ≤ 80 years of age * Eastern Cooperative Oncology Group performance status score of ≤2/Karnofsky performance status (KPS) ≥70% * Signed Institutional Review Board approved informed consent Exclusion Criteria: * \<18 years of age * Pregnant women * Concurrent severe medical problems unrelated to malignancy
References
Publications (1)
- RESULTGilbreath JJ, Semino-Mora C, Friedline CJ, Liu H, Bodi KL, McAvoy TJ, Francis J, Nieroda C, Sardi A, Dubois A, Lazinski DW, Camilli A, Testerman TL, Merrell DS. A core microbiome associated with the peritoneal tumors of pseudomyxoma peritonei. Orphanet J Rare Dis. 2013 Jul 12;8:105. doi: 10.1186/1750-1172-8-105. PMID 23844722